160435
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
导管、血管、血管成形术、球囊、外周动脉、药物输送
Spectranetics Corporation·IV·Hong Kong MDACS·Registered May 26, 2021
Device overview
- Risk class
- IV
- Product code
- 34320
- State
- current
- Status
- N/A
- Product code detail
- 34320 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
Manufacturer (製造商)
- Name
- Spectranetics CorporationSpectranetics Corporation
- Country
- United States美国
- Address
- 9965 Federal Drive, Colorado Springs, Colorado 80921, USA9965联邦驱动器,科罗拉多斯普林斯,科罗拉多州80921,美国
Authorised representative (AR)
- Name
- Innotronik Hong Kong Ltd.永创力香港有限公司
- Phone
- 28776787
Regulatory timeline
- Registration date
- May 26, 2021
- Expiry date
- December 13, 2026
Product models
Stellarex 0.035\" OTW Drug-Coated Angioplasty Balloon (A35SX040040080, A35SX040080080, A35SX040120080, A35SX050040080, A35SX050080080, A35SX050120080, A35SX060040080, A35SX060080080, A35SX060120080, A35SX040040135, A35SX040080135, A35SX040120135, A35SX050040135, A35SX050080135, A35SX050120135, A35SX060040135, A35SX060080135, A35SX060120135)
Stellarex 0.035' OTW药物涂层血管成形术球囊(A35SX040040080,A35SX040080080,A35SX040120080,A35SX050040080,A35SX050080080,A35SX050120080,A35SX060040080,A35SX060080080,A35SX060120080,A35SX040040135,A35SX040080135,A35SX040120135,A35SX050040135,A35SX050080135,A35SX050120135,A35SX060040135,A35SX060080135,A35SX060120135)
About this record
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
產品資訊： 导管、血管、血管成形术、球囊、外周动脉、药物输送